Van't Hof Edith, Sangraula Manaswi, Luitel Nagendra P, Turner Elizabeth L, Marahatta Kedar, van Ommeren Mark, Shrestha Pragya, Bryant Richard, Kohrt Brandon A, Jordans Mark J D
Department of Mental Health and Substance Use, World Health Organization, Geneva, Switzerland.
Transcultural Psychosocial Organization Nepal, Baluwatar, Kathmandu, Nepal.
Trials. 2020 Apr 19;21(1):343. doi: 10.1186/s13063-020-04263-9.
Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of five sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal.
METHODS/DESIGN: This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5-h sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20 ± 1 weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms, and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention.
This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective, the intervention manual will be released for use, giving the opportunity for further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.
ClinicalTrials.gov, NCT03747055.
在全球范围内，遭受逆境的人群缺乏心理服务，这促使一系列具有更好扩大规模特征的可扩展心理干预措施得以发展。问题管理强化疗法（PM+）是一种由非专业人员实施的为期五节的简短干预措施。它是为低收入和中等收入国家（LMIC）中受任何形式逆境影响的社区居民设计的。最近在巴基斯坦和肯尼亚进行的两项随机对照试验证明了单独实施PM+的有效性。已开发出团体版的PM+，以使干预措施更具可扩展性和可接受性。本文描述了在尼泊尔对本地改编的团体PM+进行整群随机对照试验（c-RCT）的方案。
方法/设计：这项c-RCT将在从社区招募的心理困扰程度较高的参与者中，将团体PM+与强化常规护理（EUC）进行比较。该研究设计为双臂、单盲c-RCT，将在尼泊尔东部受洪水影响的莫朗县的社区环境中进行。随机分组将在尼泊尔最小的行政级别——病房层面进行，72个登记的病房被分配到团体PM+组或EUC组（比例为1:1）。团体PM+包括五节时长约2.5小时的课程，在课程中参与者将学习应对压力源和问题的技巧，由经过培训和监督的社区心理社会工作者（CPSW）授课。EUC包括一次家庭会议，内容有（a）关于逆境和心理健康的基本信息，（b）获得支持的益处，（c）关于向配备有mhGAP培训工作人员的当地卫生设施寻求服务的信息。主要结局指标是基线后20±1周时，通过一般健康问卷（GHQ-12）测量的个体心理困扰水平。次要结局指标包括功能水平、抑郁症状、创伤后应激障碍症状、社会支持水平、躯体症状和应对方式。我们假设所获得的技能将介导干预的任何影响。
这项c-RCT将为非专业人员为受逆境影响的社区居民提供的跨诊断心理干预措施不断增加的证据基础做出贡献。如果团体PM+被证明有效，干预手册将发布以供使用，这将为在需要更好地获得心理干预措施的不同社区环境中进一步调整和实施该干预措施提供机会。
ClinicalTrials.gov，NCT03747055。
